Start-up Manager, FSP

Thermo Fisher Scientific•Wilmington, NC

2d•Onsite

About The Position

The Start-up Manager manages complex site operations and supports successful clinical study delivery by ensuring regulatory compliance, supporting site recruitment and training efforts, and facilitating collaboration between trial sites and internal teams. The role collaborates with cross-functional teams in a matrix environment to deliver site activation for assigned projects, potentially overseeing activation activities against timelines and quality standards. The manager coordinates information among PPD teams, clients, and functional departments; develops project implementation plans using PPD tools; monitors project status and reports metrics to upper management; identifies risks and develops contingency plans; and manages financial, contractual, technical, and operational aspects of site activation. The role also coordinates feasibility, site contracts, and country teams, manages assigned scope against timelines, costs, and quality, contributes to resolving complex site-activation issues, and develops customer relationships. Work is performed in an office, laboratory, and/or clinical environment. The position may involve exposure to biological fluids and infectious organisms, electrical office equipment, and required personal protective equipment. Occasional domestic and international travel of up to 20% is required and may occur outside normal business hours or on weekends. Physical requirements include remaining upright or stationary for 6–8 hours per day, frequent mobility and computer use, repetitive hand movements, occasional crouching or stooping, frequent bending and twisting, and light to moderate lifting of up to 15–20 pounds. The role requires communication, collaboration, multitasking, adaptability, and the ability to work under stress.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the role, comparable to 5+ years; an appropriate combination of education, training, and directly related experience may be considered.
Ability to work effectively and efficiently with cross-functional teams.
Knowledge of key principles of cross-functional project management.
Organizational and multitasking skills.
Attention to detail.
Ability to identify and remedy risks related to contractual deliverables and provide appropriate solutions.
Cross-cultural awareness and ability to adapt appropriately.
Comprehensive understanding of clinical research and development, including medical and therapeutic areas, phases, and medical terminology.
Ability to lead, liaise with, and coordinate cross-functional project teams.
Comprehensive knowledge and understanding of clinical development guidelines and Directives.
Ability to communicate and understand information and ideas through spoken words and sentences.
Ability to perform under stress and handle variable tasks and changing conditions.
Regular and consistent attendance.

Responsibilities

Collaborate with team members in a matrix environment to deliver site activation within assigned projects.
Potentially oversee site activation for assigned projects according to timelines and quality standards.
Coordinate information flow between PPD teams, clients, and functional departments involved in site activation.
Develop recommended project implementation plans and guidelines using PPD tools.
Monitor and analyze project status, support successful completion of assigned projects, and provide metrics to upper management.
Identify risks and provide contingency planning.
Collaborate with PPD teams to manage financial and contractual aspects of studies related to site activation.
Establish controls with the team to align project resources and expenses with budgets, with accountability to Global Project Management.
Administer technical and operational aspects of site activation, including coordinating feasibility, site contracts, and country teams in a matrix environment.
Manage assigned scope of work against timelines, costs, and quality standards.
Identify and evaluate issues affecting successful site activation, interpret complex data, make business decisions, and ensure solutions are implemented.
Develop customer relationships in alignment with assigned projects.